The drug was reviewed under Europe’s accelerated assessment program, and also picked up Orphan designation in 2013. Clinical data show patients treated with Lenvima lived on average 14.7 months longer without their disease progressing than those given a placebo.

While the CHMP concluded that the drug has a safety profile consistent with other similar therapies with “predictable and manageable” side effects, it has requested a further study to investigate the most appropriate starting dose to optimise the benefits and reduce risks.

Positive options were also handed down for: Helsinn’s Akynzeo (netupitant/palonosetron) for the prevention of chemotherapy-induced nausea and vomiting; Boehringer Ingelheim’s Synjardy (empagliflozin/metformin) for the treatment of type II diabetes; and Hospira’s generic Voriconazole Hospira (voriconazole) for the treatment of fungal infections.

The Committee also recommended extending the use of Roche’s Tamiflu (oseltamivir) to include the treatment of influenza in infants below one year of age.